Brain Stimulation and Meditation for Pain After Total Knee Arthroplasty
NCT ID: NCT05673720
Last Updated: 2025-11-24
Study Results
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View full resultsBasic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2023-05-15
2024-10-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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preoperative active tDCS+MBI
Active tDCS with simultaneous meditation intervention will be applied.
active tDCS paired with active MBM
Active tDCS with a constant current intensity of 2 milli ampere( mA)will be applied for 20 minutes per session for 5 times via the Soterix 1x1 tDCS mini-CT Stimulator device with headgear and saline-soaked surface sponge electrodes. The meditation intervention will be applied simultaneously with tDCS for 20 minutes per session for 5 times by a recorded meditation.
preoperative sham tDCS+MBI
Sham tDCS with simultaneous sham MBM intervention will be delivered.
sham tDCS paired with sham MBM
For sham stimulation, the electrodes will be placed in the same positions as for active stimulation, but the stimulator will only deliver 2 mA current for 30 seconds. The sham MBM intervention will be delivered via a CD player that will look identical in both active and sham MBM.
Interventions
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active tDCS paired with active MBM
Active tDCS with a constant current intensity of 2 milli ampere( mA)will be applied for 20 minutes per session for 5 times via the Soterix 1x1 tDCS mini-CT Stimulator device with headgear and saline-soaked surface sponge electrodes. The meditation intervention will be applied simultaneously with tDCS for 20 minutes per session for 5 times by a recorded meditation.
sham tDCS paired with sham MBM
For sham stimulation, the electrodes will be placed in the same positions as for active stimulation, but the stimulator will only deliver 2 mA current for 30 seconds. The sham MBM intervention will be delivered via a CD player that will look identical in both active and sham MBM.
Eligibility Criteria
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Inclusion Criteria
* mentally capable of reading, giving consent and following instructions
* being able to answer questions in English
* not pregnant
Exclusion Criteria
* systemic rheumatic disorders, including rheumatoid arthritis, systemic lupus erythematosus, and fibromyalgia
* alcohol/substance abuse
* current use of sodium channel blockers, calcium channel blockers and NMDS receptor antagonists
* hospitalization within the preceding year for psychiatric illness
* no access to a device with internet access that can be used for secure videoconferencing for real-time remote supervision
50 Years
85 Years
ALL
No
Sponsors
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Florida State University
OTHER
Responsible Party
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Geraldine Martorella
Principal Investigator
Locations
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Tallahassee Orthopedic Clinic
Tallahassee, Florida, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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140009-140
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
00003476
Identifier Type: -
Identifier Source: org_study_id
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